Fraud and Abuse Developments

Andrew and Quynh are law clerks at the firm and their work is supervised by licensed attorneys. Their admission to – respectively – the Washington, D.C. and California bar is pending.

On October 4, 2021, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposal by a chiropractic clinic operator to extend an existing discount program to federal health plan beneficiaries.

The requesting clinics initially offered various discount programs to their privately insured or self-paid patients, but not to Federal health care program beneficiaries. Many healthcare providers are hesitant to give federal beneficiaries access to certain discount programs because of concern that doing so would run afoul Federal anti-kickback and beneficiary inducement statutes. Specifically, the concern is that if the beneficiaries receive discounts, clinics would provide patients with something of value—a discount on self-paid services—in exchange for the option to seek federally reimbursed services through a specific provider.

To address these concerns, the chiropractic clinic operator requested an advisory opinion from OIG on a new discount model that would extend discount programs to Federal health care program beneficiaries. While OIG found that the proposed discount program could result in prohibited compensation to patients, it also stated that it would not pursue an enforcement action based on the nature of the requesting clinics’ specific discount model.

Although only the requesting chiropractic clinic operator may rely on this opinion, OIG’s analysis implies that equalizing discount rates across federally reimbursable and non-reimbursable chiropractic services reduces legal risk under anti-kickback and beneficiary inducement statutes. Providers offering similar discount programs should take note to inform their compliance strategies.
Continue Reading HHS-OIG approves uniform chiropractic discount program for federal beneficiaries

On August 12, 2021, the Seventh Circuit joined the Third, Eighth, Ninth, and D.C. Circuits in holding that the “objective reasonableness” standard for determinations of scienter, as set forth by the Supreme Court in Safeco Insurance Co. of America v. Burr, 551 U.S. 47, 70 (2007), applies in the context of False Claims Act (FCA) litigation.  In doing so, the Seventh Circuit observed that, under Safeco, a defendant cannot possess the requisite scienter under the FCA if: (1) it has an objectively reasonable reading of the statute or regulation; and (2) there was no authoritative guidance warning against its view.  This case has significant implications for defendants in FCA litigation by finding that an objectively reasonable interpretation of the law will defeat allegations of false claims.

Further, the decision is the latest victory in a spate of cases brought by the plaintiffs’ bar claiming that pharmacies are required to report special prices—such as membership club prices or matched competitor prices—as their usual and customary (U&C) prices. Virtually every pharmacy that has operated a membership club has faced scrutiny through actions under the FCA and consumer-class actions. The Seventh Circuit’s decision comes in the wake of the recent jury verdict in favor of CVS in the matter of Carl Washington (formerly known as Corcoran) et al. v. CVS Pharmacy, Inc., No. 15-cv-03504 (N.D. Ca. Jun. 24, 2021).   This victory will support pharmacies’ defenses in other similar litigation alleging the submission of false U&C prices, particularly when the alleged false conduct occurred before 2016, given that the Seventh Circuit found that reporting retail prices—as opposed to special prices such as price matches—was an objectively reasonable approach to U&C reporting.

The Lower Court’s Decision:
Continue Reading Seventh Circuit adopts Safeco objective reasonableness standard in the context of false claims act cases

In recent years, the U.S. Department of Justice (“DOJ”) has increasingly leveraged data analytics to combat fraud. Principal Deputy Chief of DOJ’s Fraud Section, Joe Beemsterboer, described the department’s data-mining capabilities as the “foundation of how [DOJ] investigate[s] and analyze[s] cases,” and explained that digital forensics equips the department with “powerful” tools for identifying “trends,”

The Department of Health and Human Services (HHS) released complementary rules this past Friday, November 20, 2020, to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the federal Anti-Kickback Statute.

As we wrote when the proposed rules were released last autumn (see client alerts here and here),

On August 4, 2020, the Ninth Circuit, in a decision authored by Judge Wardlaw, dismissed for lack of jurisdiction an atypical appeal filed by the Federal Government from a district court’s order denying the Government’s motion to dismiss a qui tam case filed under the False Claims Act (“FCA”).  See United States v. United States

The much-anticipated final rules modernizing the safe harbors under the Anti-Kickback Statute (AKS) and the physician self-referral exceptions under the Stark Law are officially under review by the Office of Management and Budget (OMB). The Department of Health and Human Services (HHS) anticipates publishing the final rules in August 2020, although that target date is

Pennsylvania Attorney General Josh Shapiro announced on May 12, 2020, that his office is investigating several nursing homes in the Commonwealth for neglect of patients and residents: “We will hold nursing facilities and caretakers criminally accountable if they fail to properly provide care to our loved ones … we will not tolerate those who mistreat our seniors and break the law.” Shapiro has also launched a public portal for citizens to email reports of neglect in nursing home communities. As is the case in many states, nursing home patients make up the majority of the deaths associated with COVID-19 in Pennsylvania. Just over 2,611 nursing home residents and staff have died from COVID-19 in Pennsylvania, comprising nearly 70 percent of the 3,800 total deaths reported in the Commonwealth as of the date of the press release.

Attorney General Shapiro is not alone in his effort to take a closer look at nursing home facilities and caregivers, even while lobbying groups for health care providers and nursing homes push for broad immunity from coronavirus-related lawsuits. In late April, New York Attorney General Letitia James released a statement saying that her office’s Medicaid Fraud Control Unit continues to investigate allegations of abuse and neglect in nursing homes. James’ office similarly launched a nursing home abuse hotline for residents, families, and members of the public to report alleged complaints at the facilities. Specifically, Attorney General James is investigating a Queens adult care facility that allegedly failed to protect residents from COVID-19 and misled families about its spread. Residents of that same facility are now suing in federal court over similar allegations. State attorneys general are increasingly active on this issue and will be pursuing nursing homes and long-term care facilities through various angles including Medicaid fraud, consumer protection, and false advertising.Continue Reading Nursing homes face increased scrutiny by attorneys general during COVID-19

The Centers for Medicare & Medicaid Services (CMS) has published a final rule with comment period establishing sweeping disclosure and monitoring obligations for providers and suppliers enrolled or enrolling in federal health programs, and expanding CMS’s authority to deny or revoke enrollment status.  In particular, the rule establishes an expansive new “affiliations” disclosure requirement that

As part of its “Regulatory Sprint to Coordinated Care,” the Centers for Medicare & Medicaid Services (CMS) is seeking input on how it can address “unnecessary obstacles to coordinated care, real or perceived, caused by the physician self-referral law.” CMS Administrator Seema Verma acknowledged in a recent blog post that “[i]n its current form, the

Federal health fraud recoveries for FY 2017 totaled $2.6 billion, according to the latest HCFAC program annual report, compared to $3.3 billion in FY 2016. The Department of Justice (DOJ) opened 967 new criminal health care fraud investigations in FY 2017, filed criminal charges in 439 cases involving 720 defendants, obtained convictions of 639

The Department of Justice (DOJ) obtained $3.7 billion in False Claims Act (FCA) settlements and judgments in fiscal year (FY) 2017, with $2.4 billion coming from health care industry cases. The $2.4 billion amount includes only federal recoveries; additional funds were recovered for state Medicaid programs.  The largest health care industry recoveries in FY 2017–

A recent False Claims Act (“FCA”) settlement involving an allegedly overpaid Florida medical practice reaffirms the interplay between the 60-Day Overpayment Statute and the FCA, but also highlights the importance for all providers and suppliers to report and return overpayments, regardless of the source of federal funds.

According to the Department of Justice (“DOJ”), First Coast Cardiovascular Institute (“FCCI”) allowed credit balances from various federal health care programs to accrue despite multiple internal warnings that the balances should be paid back. DOJ alleged that FCCI’s failure to return those credit balances within 60 days violated the FCA. DOJ’s comments are notable, however, because the credit balances not only involved Medicare and Medicaid, but also TRICARE and the Department of Veterans Affairs, both of which are outside the scope of the 60-Day Overpayment Statute. DOJ and FCCI resolved the alleged $175,000 in unreturned overpayments for a $448,821.58 price.
Continue Reading DOJ Settles Second 60-Day Overpayment Case, Highlights Broader Reach of the FCA’s Reverse False Claims Provision

The OIG has released national and state-by-state data quantifying State Medicaid Fraud Control Unit (MFCUs) accomplishments in fiscal year 2016. During this period MFCUs were credited with a total of:

  • 1,721 indictments (1,249 involving fraud and 472 involving abuse or neglect);
  • 1,564 convictions (1,160 involving fraud and 404 involving abuse or neglect);
  • 998 civil

Federal health fraud recoveries for FY 2016 totaled $3.3 billion, according to the latest HCFAC program annual report.  The HCFAC program is credited with more than $31.0 billion in Medicare Trust Funds recoveries since it began in 1997. With regard to criminal fraud, the Department of Justice (DOJ) opened 975 new criminal health care

On June 22, 2016, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a comprehensive report detailing its nationwide analysis of common characteristics in home health fraud cases. In tandem with this report, the OIG issued an Alert on improper arrangements and conduct by and among home health agencies (“HHAs”) and physicians. Essentially, the OIG has broadcast a warning shot—it will increase its already aggressive prosecution of home health services fraud.

The Centers for Medicare & Medicaid Services (“CMS”) has also stepped up its own efforts to combat health care fraud. Specifically, the agency announced that it will implement a pre-claim review demonstration for HHAs in five states — Illinois, Florida, Texas, Michigan, and Massachusetts — identified as particularly susceptible to home health services fraud. This pre-claim review demonstration mandates that HHAs seeking Medicare reimbursement for home health services submit currently-mandated documentation to the Medicare Administrative Contractor (“MAC”) earlier in the claims payment process.  Although HHAs need not wait for a determination prior to furnishing services, the documentation is intended to determine if the service level complies with Medicare coverage requirements. CMS intends this review process to aid investigative and enforcement efforts by both CMS and OIG.Continue Reading OIG, CMS Focus New Scrutiny on Home Health Industry: Additional Investigative and Enforcement Activity Likely to Follow

Today the Department of Justice published an interim final rule with request for comments that applies an inflation adjustment to civil monetary penalty (CMP) amounts assessed by the Department, as mandated by the Bipartisan Budget Act of 2015.  Notably, the new maximum CMP for False Claims Act (FCA) violations under 31 U.S.C. 3729(a) is

The Centers for Medicare & Medicaid Services (“CMS”) published the long-awaited final rule February 12, 2016, clarifying the specific procedures applicable to the statutory requirement under the Affordable Care Act (“ACA”) for providers and suppliers to report and return overpayments within 60 days. While the final rule eased some of the law’s more unforgiving aspects, its limited scope brought up new questions about the breadth of the law itself.

Despite concerns raised by a number of commenters in response to the proposed rule, CMS limited the scope of the final rule to Medicare Parts A and B only. In other words, the final rule clarifies the obligations of Medicare providers and suppliers to report and return overpayments originating under Medicare Parts A and B. Commenters expressed concern about this limitation and the lack of rationale for distinguishing Medicare Parts A and B from Medicare Parts C and D; they also voiced the need shared by all providers and suppliers for guidance on the overpayment requirements. In response, CMS reasoned that differences in how the Medicare programs are administered necessitated separate rulemakings. Interestingly, the agency did not indicate whether a separate rulemaking would be forthcoming, but instead directed providers and suppliers to their existing statutory obligations under the ACA, and a prior rulemaking applicable to reporting and returning overpayments in the Medicare Parts C and D context, for further guidance. In its response, CMS appears to assume, without stating expressly, that the law and the agency’s prior rulemaking apply to providers and suppliers receiving payments under Parts C and D.

Continue Reading So You’re an Overpaid Medicare Part C/D Provider or Supplier: Can You Keep the Change?

The federal government won or negotiated more than $1.9 billion in judgments and settlements, and attained additional administrative impositions in health care fraud cases and proceedings in FY 2015, according to the latest HCFAC program annual report. These new efforts, together with prior year actions, resulted in a total of $2.4 billion in health fraud recoveries for FY 2015, $1.6 billion of which was transferred to the Medicare Trust Funds. The HCFAC program has been responsible for more than $29.4 billion in Medicare Trust Funds recoveries since it began in 1997.
Continue Reading Health Care Fraud and Abuse Control (HCFAC) Program Logs $2.4 Billion in Recoveries for FY 2015